高效液相色谱法测定复方维生素B_6乳膏中维生素B_6和醋酸泼尼松的含量

Determination of Vitamin B_6 and Prednisone Acetate in Compound Vitamin B_6 Cream by RP-HPLC

目的:建立同时测定复方维生素B6软膏中维生素B6和醋酸泼尼松含量的反相高效液相色谱法。方法:采用Hyper- sil C18柱(250 mm×4.0 mm,5μm),流动相为磷酸二氢钾,庚烷磺酸钠溶液(取磷酸二氢钾6.8 g,庚烷磺酸钠1.0 g,加水溶解并稀释至1 000 ml)-甲醇-三乙胺(35:65:0.3),用磷酸调pH值为3.2,检测波长242 nm。结果:维生素B6在22.12-176.8μg ·ml-1范围内,醋酸泼尼松在6.92-55.4 μg·ml-1。范围内呈线性关系,维生素B6的平均回收率为99.6%,RSD=1.09%(n= 5),醋酸泼尼松的平均回收率为99.6%,RSD=1.89%(n=5)。结论:本方法简便,结果准确,可用于本制刺的含量测定和质量控制。

Objective: To establish a RP-HPLC method for determination of vitamin B6 and prednisone acetate in compound vitamin B6 cream. Method: The Hypersil C18 column(250 mm×4.0 mm,5 μm)was used, the mobile phase consisted of potassium di-hydrogen phosphate, sodium heptanesulfonate solution (dissolved the potassium dihydrogen phosphate 6, 8 g and sodium heptanesul-phonate 1.0 g in water,and add water to 1 000 ml) methanol-triethylamine(35:65:0. 3) , adjusted pH to 3. 2 with phosphoric acid, the detecting wavelength was at 242 nm. Result: The calibration curve were linear within a range of 22. 12 - 176. 8 μg·ml-1 for vitamin B6 ,and 6. 92-55. 4 μg·ml-1 for predisone acetate, the average recoveries were 99. 6% , RSD = 1. 09% ( n = 5 ) for vitamin B6, and 99.6% ,RSD = 1. 89% (n =5) for prednisone acetate. Conclusion: This method is simple and accurate, it can be used for the content determination and quality control of this preparation.